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Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01508936
First received: January 3, 2012
Last updated: May 26, 2016
Last verified: May 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Eosinophilic Asthma
Interventions: Drug: Reslizumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 869 patients were screened for enrollment into this study. Of the 869 patients screened, 511 patients at 103 centers in the US met entry criteria and were considered to be eligible for enrollment into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified by occurrence of asthma exacerbation(s) during the previous year (yes or no). Within each stratum, patients were randomly assigned in a 4:1 ratio to receive treatment with reslizumab at 3.0 mg/kg or matching placebo.

Reporting Groups
  Description
Placebo Placebo intravenous injection every 4 weeks for a total of 4 doses.
Reslizumab 3.0 mg/kg Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.

Participant Flow:   Overall Study
    Placebo     Reslizumab 3.0 mg/kg  
STARTED     102     409  
Randomized, Not Analyzed     4 [1]   11 [1]
Randomized     98     398  
Randomized, Not Treated     1     3  
Safety Analysis Set     97     395  
Full Analysis Set     97     395  
FEV1 Subpopulation Analysis Set     91     346  
COMPLETED     79     330  
NOT COMPLETED     23     79  
Adverse Event                 11                 32  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 4                 18  
Protocol Violation                 2                 3  
Lost to Follow-up                 2                 9  
Not specified                 0                 5  
Data from 2 sites deemed invalid                 4                 11  
[1] Participants from two centers were omitted from all analyses.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized, analyzed

Reporting Groups
  Description
Placebo Placebo intravenous injection every 4 weeks for a total of 4 doses.
Reslizumab 3.0 mg/kg Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
Total Total of all reporting groups

Baseline Measures
    Placebo     Reslizumab 3.0 mg/kg     Total  
Number of Participants  
[units: participants]
  98     398     496  
Age  
[units: years]
Mean (Standard Deviation)
  45.1  (13.38)     44.9  (12.00)     44.9  (12.27)  
Gender  
[units: participants]
     
Female     54     261     315  
Male     44     137     181  
Race/Ethnicity, Customized  
[units: participants]
     
White     73     260     333  
Black     21     113     134  
Asian     2     10     12  
American Indian or Alaskan Native     0     3     3  
Pacific Islander     2     0     2  
Other     0     12     12  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic and Non-Latino     90     354     444  
Hispanic or Latino     8     44     52  
Weight  
[units: kg]
Mean (Standard Deviation)
  90.9  (20.68)     90.6  (23.92)     90.7  (23.30)  
Height  
[units: cm]
Mean (Standard Deviation)
  169.7  (10.25)     167.7  (10.35)     168.1  (10.35)  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  31.6  (6.66)     32.2  (8.69)     32.2  (8.33)  
Asthma Control Questionnaire (ACQ) [1]
[units: units on a scale]
Mean (Standard Deviation)
  2.564  (0.6909)     2.558  (0.6992)     2.559  (0.6969)  
Forced Expiratory Volume in 1 second (FEV1) [2]
[units: liters]
Mean (Standard Deviation)
  2.180  (0.6355)     2.101  (0.6950)     2.117  (0.6837)  
Forced Vital Capacity (FVC) [2]
[units: liters]
Mean (Standard Deviation)
  3.215  (0.9076)     3.047  (0.9577)     3.081  (0.9494)  
Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) [3]
[units: liters/second]
Mean (Standard Deviation)
  1.553  (0.6791)     1.650  (0.9037)     1.631  (0.8645)  
Percent Predicted Forced Expiratory Volume in 1 Second (% predicted FEV1) [2]
[units: % predicted]
Mean (Standard Deviation)
  66.5  (15.53)     66.8  (16.26)     66.7  (16.10)  
Blood Eosinophil Counts [4]
[units: 10^9 blood eosinophil/liter]
Mean (Standard Deviation)
  0.277  (0.2209)     0.281  (0.2448)     0.280  (0.2401)  
Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) in Past 3 Days [5]
[units: puffs of SABA/day]
Mean (Standard Deviation)
  2.0  (1.82)     1.9  (1.84)     1.9  (1.83)  
[1] n=98, 396, 494 The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control.
[2] n=98, 396, 494
[3] n=96, 393, 489
[4] n=96, 397, 493
[5] n=98, 395, 493



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set   [ Time Frame: Baseline (Day 1), Week 16 ]

2.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, 16 ]

3.  Secondary:   Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, 16 ]

4.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation   [ Time Frame: Baseline (Day 1), Week 16 ]

5.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]

6.  Secondary:   Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]

7.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]

8.  Secondary:   Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, and 16 ]

9.  Secondary:   Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16   [ Time Frame: Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16 ]

10.  Secondary:   Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28) ]

11.  Secondary:   Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16   [ Time Frame: Baseline (Day 1), Weeks 4, 8, 12 and 16 ]

12.  Secondary:   Participants With Treatment-Emergent Adverse Events   [ Time Frame: Day 1 to Week 28 ]

13.  Secondary:   Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values   [ Time Frame: Week 4 to Week 16 ]

14.  Secondary:   Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values   [ Time Frame: Week 4 to Week 28 ]

15.  Secondary:   Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities   [ Time Frame: Week 16 or endpoint ]

16.  Secondary:   Participants With a Positive Anti-Reslizumab Antibody Status During Study   [ Time Frame: Screening (Week -3), Weeks 8 and 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com



Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01508936     History of Changes
Other Study ID Numbers: C38072/3084
Study First Received: January 3, 2012
Results First Received: March 23, 2016
Last Updated: May 26, 2016
Health Authority: United States: Food and Drug Administration